In 2013, the Food and Drug Administration (FDA) released a final rule establishing a unique device identification system designed to adequately identify devices through distribution and use. The final rule requires device labelersto include a unique device identifier (UDI) on device labels and packages, except where the rule provides for an exception or alternative. Each UDI must be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI will also be required to be directly marked on a device that is intended for more than one use, and intended to be reprocessed before each use. Dates on device labels and packages are to be presented in a standard format that is consistent with international standards and international practice.

A UDI is a unique numeric or alphanumeric code that consists of two parts:

a device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device, and

a production identifier (PI), a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device:the lot or batch number within which a device was manufactured;

the serial number of a specific device;

the expiration date of a specific device;

the date a specific device was manufactured;

the distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device.

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